COVID Vaccines/Therapeutics – Developer/Manufacturer Announcements
[Selected press releases/announcements from organizations from WHO EUL/PQ listing above and other organizations]

 

AstraZeneca
Press Releases – No new digest announcements identified

Bharat Biotech
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – No new digest announcements identified

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News – No new digest announcements identified

 

Gamaleya National Center
Latest News and Events – See Russia below

IMBCAMS, China
Home – Website not responding at inquiry

 

Janssen/JNJ
Press Releases – No new digest announcements identified

 

Moderna
Press Releases
February 9, 2022
Moderna Chief Technical Operations and Quality Officer Juan Andres Elected to National Academy of Engineering

February 8, 2022
Moderna Announces New Supply Agreement with Colombia for Additional 10.8 Million Doses of Moderna’s COVID-19 Vaccine

 

Novavax
Press Releases
Novavax Statement on First Administration of its COVID-19 Vaccine in Australia
Feb 11, 2022
The first dose of Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) was administered today in Australia during a press briefing by The Hon Greg Hunt MP, Federal Minister for Health and Aged Care. Nuvaxovid is the first protein-based COVID-19 vaccine to receive approval for provisional registration by the Therapeutic Goods Administration (TGA)…

Novavax Announces Positive Results of COVID-19 Vaccine in Pediatric Population of PREVENT-19 Phase 3 Clinical Trial
Feb 10, 2022
– PREVENT-19 pediatric expansion in adolescents aged 12 through 17 achieved primary effectiveness endpoint demonstrating comparability to adult population
– Trial demonstrated 82% clinical efficacy against Delta variant
– Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied
– Vaccine was well-tolerated with no safety signals identified
– Novavax plans to supplement global regulatory filings with pediatric data in Q1 2022

 

Pfizer
Recent Press Releases
02.11.2022
Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA.
The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.
In December 2021, Pfizer and BioNTech announced that the ongoing clinical study would evaluate a third 3 µg dose at least two months after the second dose of the two-dose series in this age group. Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen. The companies expect to have three-dose protection data available in early April.
The independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well tolerated and support a potential three-dose regimen.
The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion.

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified

 

Sinopharm/WIBPBIBP
News – No new digest announcements identified

 

Sinovac
Press Releases – No new digest announcements identified

 

Vector State Research Centre of Viralogy and Biotechnology
Home – No new digest announcements identified

Zhifei Longcom, China
[Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.]
[No website identified]

 

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GSK
Press releases for media – No new digest announcements identified

 

Merck
News releases
Merck and Ridgeback Announce That 3.1 Million Courses of Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Have Been Supplied to the U.S. Government for Use in the United States
February 08, 2022

 

Novartis
News – No new digest announcements identified

 

SK Biosciences
Press releases
SK bioscience Begins Shipment of First Authorized Protein-Based COVID-19 Vaccine
– A vaccine platform with long-term well-understood safety and efficacy is expected to induce more participants to vaccination who are reluctant to.
– SK started supplying 2 million doses of Nuvaxovid from L-House.
– A total of 40 million doses will be distributed for domestic use in Korea.

 

Valneva
Press Releases – No new digest announcements identified